Influences of Multivitamin Supplementation on Health Parameters

NCT ID: NCT03071796

Last Updated: 2017-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-07
• Study Completion Date: 2017-06-20

Brief Summary

In this study the investigator will evaluate whether a liquid multivitamin supplement influences blood and vital parameters. Furthermore the investigator will establish the effects on life quality, mood and perception of stress and will characterize changes on immune system.

Detailed Description

The double-blind, randomized intervention study is conducted for 12 weeks and includes two groups (placebo versus verum) with same number of participants.

The investigator aims to determine the effects of multivitamin supplement on blood and vital parameters which includes blood pressure, pulse, heart rate, variability of heart rate, vitamin D, vitamin B12, folic acid, homocysteine, HbA1c. Furthermore the investigator will access life quality, mood and perception of stress through the following questionnaire POMS, PSS-10, SF12 & SF36. The investigator will evaluate whether the multivitamin supplement changes the frequency of diseases like cold which represents the function of the immune system.

Conditions

Health Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

multivitamin supplement

liquid multivitamin supplement for 12 weeks

Group Type: EXPERIMENTAL

multivitamin supplement

Intervention Type: DIETARY_SUPPLEMENT

supplement includes 97 natural extracts

placebo

liquids with similar appearance and taste like multivitamin supplement for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

liquids with similar appearance and taste like multivitamin supplement for 12 weeks

Interventions

multivitamin supplement

supplement includes 97 natural extracts

Intervention Type: DIETARY_SUPPLEMENT

Placebo

liquids with similar appearance and taste like multivitamin supplement for 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• healthy women and men
• age between 30-60 years
• employed

Exclusion Criteria

• acute and chronic diseases (including diabetes, inflammatory bowel diseases, dementia, multiple sclerosis)
• frequent use of alcohol, drugs or cigarettes (>5 cigarettes / day)
• use of additional supplements
• use of medications (e.g. antihypertensive medications, lipid reducers, thyroid medication)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Martin-Luther-Universität Halle-Wittenberg

OTHER

Sponsor Role: lead

Responsible Party

Kuno Hottenrott, Prof.

Prof. Dr.; University of Halle-Wittenberg, Department of Sports

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kuno Hottenrott, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Halle-Wittenberg, Department of Sports

Locations

University of Halle-Wittenberg

Halle, , Germany

Countries

Germany

Other Identifiers

ILUG-201701

Identifier Type: -

Identifier Source: org_study_id